8mm HTR Sterile Hammer Toe Reaming Kit, Material: Stainless Steel, Sterile: R, PX only, UDI: (01)00812926022345(17)23122

FDA device recall Z-1635-2020 · posted 2020-04-01 · Terminated

Recall details

Recalling firm

Trilliant Surgical, LLC

Reason for recall

The firm has identified that parts from the kit, lot: TSL007202, have the potential to contain the incorrect contents of the 8mm HTR Sterile Hammer Toe Reaming Kit. The kit should contain (2) reamers total, (1) Concave Reamer and (1) Convex Reamer; there is the potential that kits from the identified lot may have (2) of the same reamer type as opposed to one (1) of each type.

Action taken

The recall strategy included sending complete recall communication and response forms as of 11/04/2019 via FedEx (Express Standard Overnight) to all consignees that showed possession / had been sold a device as of 10/30/2019. The recall communication included the following actions to be taken by the distributor/customer: 1. Check inventory stock for the identified device. 2. Open the shipper box* on the end opposite of the label and remove the internal packaging. *Note: Opening the shipper box does not disrupt the sterile barrier. The double sterile barrier is maintained within the internal packaging. 3. Through the transparent internal packaging, verify that the kit contains the appropriate quantity and type of each reamer; (1) Concave Reamer and (1) Convex Reamer. If product in possession IS identified as affected by containing (2) of the same reamer type, quarantine and/or discontinue use of the device and return the affected device(s) to the firm in accordance with the included Return Response (Acknowledgment and Receipt Form). If product in possession IS NOT affected (i.e. there is 1 Concave Reamer and 1 Convex Reamer within the packaging, complete and return the included Return Response (Acknowledgment and Receipt Form). THE INCLUDED RETURN RESPONSE IS REQUIRED EVEN IF AFFECTED PRODUCT IS NOT IDENTIFIED. For questions regarding the communication, the phone number is 800.495.2919.

Root cause

Mixed-up of materials/components

Status

Terminated

Product code

HTY

Quantity affected

117

Distribution

Distributors in 21 states: AR, AZ, CA, FL, GA, IA,IN, KS, KY, MN, MO, NC, ND, NJ, NY, OH, TN, TX, UT, WA, and WI.

Date initiated

2019-11-04

Date posted

2020-04-01

Date terminated

2021-04-28

Location

Houston, TX

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